Sarilumab is proving effective for treating RA. In a clinical trial, pregabalin did not meet its endpoint for treating post-traumatic peripheral neuropathic pain. And a 12-hour ibuprofen patch is in development…
Combo Drug for Arthritis & Hypertension Meets Goal in Phase 3 Study
(Reuters)—Kitov Pharmaceuticals Holdings Ltd. said on Tuesday its lead drug, KIT-302, met the main goal of a late-stage study, reducing pain without increasing the risk of heart diseases in patients with osteoarthritis. Israel-based Kitov says its drug does not need to be labeled with health warnings, but will instead say it reduces the risk of…
FDA Approves Drug to Counter Opioid ODs
The FDA recently approved a form of naloxone hydrochloride in a nasal spray that will help counter opioid overdoses. The FDA also approved an ibuprofen injection as an adjunct to opioids for use in children 6 months and older…
Oxycodone Capsules Put on Hold; Clinical Trials for Lupus Nephritis & SLE Therapies
Due to a lawsuit, the FDA has issued only tentative approval for an extended-release oxycodone capsule. Obinutuzumab is in clinical trials for lupus nephritis, and subcutaneous belimumab is being tested for SLE…
FDA Approves 2 Pain Drugs & New Gout Treatment on Road to Approval
The FDA has approved two drugs designed to manage pain: buprenorphine for chronic pain and meloxicam capsules for OA pain. Lesurinad is also closer to FDA approval for treating gout…
Ustekinumab Can Be Used to Safely Treat Teens & More
A recent study showed ustekinumab can be used to treat teens with moderate to severe psoriasis. Also, Phase 2 trials for an analgesic combination drug show it holds promise for reducing post-operative pain…
Rituximab for RA Is Safe Long Term, Plus Oxycodone Update
Rituximab was evaluated and found safe as a long-term RA therapy. Also, FDA Advisory Committees voted on oxycodone therapies at a joint meeting.
Pfizer Loses UK Patent Case over Use of Lyrica Drug for Pain
LONDON (Reuters)—Pfizer suffered a major setback in Britain on Thursday when the High Court in London ruled that claims of patent protection for the use of its $5 billion-a-year drug Lyrica as a pain treatment were invalid. Lyrica, known generically as pregabalin, was originally developed for epilepsy. However, further research showed it could also help patients…
Pacira Sues FDA over Pain Drug Marketing Restrictions
NEW YORK (Reuters)—Pacira Pharmaceuticals Inc. on Tuesday filed a lawsuit seeking a court order allowing it to promote its post-surgery pain drug, Exparel (bupivacaine liposome injectable suspension), for a wide range of surgeries, which the U.S. Food and Drug Administration opposes. The lawsuit, filed in federal court in Manhattan, cites another New York judge’s recent…
FDA Issues Stronger NSAIDs Warning
The FDA revised its warning and labeling recommendations for antiinflammatory drugs because of a greater understanding of the increased risks they pose for stroke and myocardial infarction…